Acute Pseudophakic Cystoid Macular Edema
Conditions
Brief summary
To compare bromfenac 0.09%, diclofenac sodium 0.1%, and ketorolac tromethamine 0.5% ophthalmic solutions for the treatment of acute pseudophakic CME after cataract surgery.
Interventions
DRUGBromfenac
1 drop (in the eye) Instill one drop in the affected eye twice daily for three months
DRUGKetorolac
1 drop (in the eye) Instill one drop in the affected eye four times daily for three months
DRUGDiclofenac
1 drop (in the eye) Instill one drop in the affected eye four times daily for three months
Sponsors
Bp Consulting, Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients must be diagnosed with acute pseudophakic CME within 12 months of cataract surgery * Males and females 18 years and older * Able to provide written informed consent
Exclusion criteria
* Complicated cataract surgery, particularly posterior capsule rupture and vitreous loss * Pre-Existing macular pathology, including macular edema, macular scar, macular hole, or macular pucker * History of Uveitis * Ipsilateral intraocular surgery prior to cataract surgery * CME greater than one year duration
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Acute Pseudophakic Cystoid Macular Edema | 5 months |
Secondary
| Measure | Time frame |
|---|---|
| Visual Acuity | 5 months |
Countries
United States
Outcome results
None listed